NCT06589401

Oral Paclitaxel for Patients with Advanced Solid Tumors

A Phase I Trial Evaluating the Safety, Tolerability, and Pharmacokinetic Profile of INP12 in Patients with Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: InnoUp Farma S.L. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Phase I trial evaluating the safety, tolerability, and pharmacokinetic profile of INP12, a nanoparticles-based oral paclitaxel, in patients with advanced solid tumors The aim in Part A (Escalation phase) is to determine the maximum tolerated dose (MTD) or the highest protocol-defined dose (in the absence of exceeding the MTD)and the recommended phase II dose (RP2D) of INP12 administered orally once a week during three consecutive weeks under a 28-day cycle in patients with advanced solid tumors. The aim in Part B (Expansion phase) is to assess the safety and tolerability of INP12 as monotherapy at the RP2D or highest protocol-defined dose in patients with selected advanced solid tumors.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	INP12	Oral paclitaxel

Timeline

• Start date: 2022-09-01
• Primary completion: 2025-10-01
• Completion: 2026-04-01
• First posted: 2024-09-19
• Last updated: 2024-09-19

Locations

1 site across 1 country: Spain